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

This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

Inclusion Criteria: 1. Willing and capable of providing informed consent 2. Willing and capable of receiving the study procedure and returning for all follow-up evaluations and sleep studies 3. Willing and capable of completing all questionnaires 4. Age is 22 to 70 years old 5. Not able to use, refuse to use, or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Devices (MAD) 6. BMI of ≤ 40 kg/m2 at enrollment 7. AHI \>=30 at enrollment based on in-lab polysomnography study OR AHI ≥ 15 and BMI of \>= 30 at enrollment based on in-lab polysomnography study Exclusion Criteria: General Exclusions 1. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing 2. Any reason the investigator deems the subject unfit for participation in the study Concomitant Medication Exclusions 3. Actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender or \>65 years of age 4. Actively undergoing immunotherapy (Allergy shots), or unwilling to washout of allergy shots at least 2 weeks prior to study procedure 5. Patients taking any of the following medication that could affect study endpoints: benzodiazepines, Z-drugs (zolpidem and eszopiclone) opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil) 6. Currently on stable GLP-1 medication dosing and unwilling to commit to maintaining that dose until completion of the 6-month assessment post-procedure. 7. Currently titrating GLP-1 medication and unwilling to discontinue use 1 month prior to procedure date and commit to not to re-start until completion of the 6-month assessment post-procedure Medical History Exclusions 8. Prior sleep surgeries, including tongue base reduction or palatoplasty (with exception of tonsillectomy and/or adenoidectomy) 9. Previous surgery (non-OSA) within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils) 10. Patients with severe, uncontrolled asthma 11. History of angioedema/swelling of the airway 12. Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema confirmed with a compliment component C4 blood test \