Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (OASIS)

The objective of this study is to evaluate the safety and effectiveness of the Cryosa System when used as intended to perform the Cryosa Procedure.

Inclusion Criteria: 1. Participant age is 22 years and older 2. Participant has failed, is unable to use, unwilling to use or dissatisfied with Positive Airway Pressure (PAP) or mandibular advancement devices (MAD) 3. Participant is diagnosed with Obstructive Sleep Apnea with an AHI ≥30 OR AHI ≥ 15 and BMI of ≥ 30 at enrollment (CA/MA ≤ 25%) 4. Participant is willing and capable of receiving the study procedure, completing all the questionnaires and returning for all follow-up evaluations and sleep studies 5. Participant is willing and capable of providing informed consent Exclusion Criteria: 1. Participant is currently participating in other premarket investigational studies unless approved by Sponsor in writing 2. Any reason for which, in the judgment of the investigator, the participant is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study (e.g. uncontrolled Type 1 or 2 diabetes with neuropathy, debilitating acute or chronic cardiac, lung, liver, kidney, central nervous system or psychiatric disease) 3. Participant has a BMI \> 40 kg/m2 at enrollment 4. Women who are pregnant or of childbearing potential (WOCBP defined as fertile following menarche and until becoming post-menopausal unless permanently sterile) who are unwilling to practice an appropriate method of contraception from screening through 6-month follow-up. Concomitant Medication Exclusions 5. Participant is actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender, or \>65 years of age 6. Participant is actively undergoing immunotherapy (Allergy shots), and unwilling to wash out of allergy shots at least 2 weeks prior to study procedure 7. Participant is taking any of the following medications that, in the opinion of the investigator, could affect study endpoints: AD109, benzodiazepines, Z-drugs (zolpidem and eszopiclone), opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil) Significant Airway Risk Factors 8. Participants with severe uncontrolled asthma 9. Participants with a history of angioedema 10. Participants with hereditary angioedema (confirmed with a Complement Component C4 blood test \9 at time of screening. 31. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (\< 12 months) myocardial infarction or severe cardiac arrhythmias 32. Participants with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months 33. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months 34. Participant has contraindication to general anesthesia or, in the opinion of the Investigator, would not be able to tolerate the procedure, including intubation during the procedure Lifestyle considerations 35. Participant is a current smoker or nicotine vaper (\>1 pack/day or equivalent) 36. Participant conducts work or regular activities requiring vigilance (e.g., commercial driver, heavy machine operator, shift worker, etc.) that does not accommodate untreated OSA. 37. Participant has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG 38. Participant exhibits ongoing misuse of alcohol or recreational drugs that would impact either the results of or the participation in a sleep study