(1215) Comparative Safety of Posterior Nasal Nerve Cryoablation and Radiofrequency Ablation: A MAUDE Database Study

Introduction: Posterior nasal nerve (PNN) ablation using cryotherapy or radiofrequency is an established treatment for chronic rhinitis refractory to traditional intranasal medical therapy. However, comparative safety data between these emerging modalities remain limited. This study evaluates reported adverse events associated with different PNN ablation devices.

Methods: The FDA Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of adverse events related to PNN ablation using cryotherapy (ClariFix) or radiofrequency (RhinAer) from January 1, 2020, to present. Two independent reviewers categorized events based on report narratives. Descriptive statistical analyses were performed using IBM SPSS. This study was deemed to be IRB exempt as all data were publicly available and de-identified.

Results: A total of 100 reports were identified, of which 34 were associated with radiofrequency ablation (RhinAer) and 66 with cryotherapy ablation (Clarifix). Overall complication rates were significantly higher with radiofrequency compared with cryotherapy (88.24% vs. 33.33%, p< 0.000001) as were events requiring clinical management (91.18% vs. 62.12%, p < 0.005). Device-related complications were more common with ClariFix (66.67% vs. 11.76%, p< 0.000001). Epistaxis occurred more frequently following RhinAer than ClariFix use (76.46% vs. 28.79%, p< 0.0000001). ClariFix was associated with unique complications, including unrestricted nasal flow (n=43, 65.15%), nasal congestion (n=1, 1.52%), and vasovagal response (n=1, 1.52%), whereas RhinAer was uniquely associated with infection (n=1, 2.94%) and hypoesthesia (n=1, 2.94%).

Conclusions: Radiofrequency-based PNN ablation demonstrated higher overall complication rates, particularly epistaxis and events requiring clinical intervention, whereas cryotherapy showed a greater proportion of device-related complications. These findings highlight distinct safety profiles that should inform otolaryngologists of optimal device selection and proper patient counseling.