Adverse Events in Cryoablation and Radioablation Treatment of Chronic Rhinosinusitis: A MAUDE Database Comparative Analysis

Introduction: Cryoablation and radioablation of the posterior nasal nerve are two increasingly popular procedural approaches for treatment of chronic vasomotor rhinitis. They are marketed as convenient, in-office procedures with lower risks than traditional surgical options like vidian neurectomy. However, there are limited studies evaluating adverse events with these procedures. This study aims to analyze and compare adverse events (AEs) associated with cryoablation and radioablation.

Methods: The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for AEs associated with Clarifix (cryoablation) and RhinAer (radioablation) devices, using product codes GEH and GEI. These reports are volunteered by healthcare professional reporters. Reports from 3/2017 to 10/2025 were included. AEs were included if device problems were categorized as an “Adverse Event” and excluded if not. Duplicates were excluded. An established MAUDE complication-reporting stratification, based on the Clavien-Dindo scale, was used to grade complication severity. AEs were categorized by event date, manufacturer, patient problem, specific outcomes, and event onset.

Results: 31 Clarifix and 31 RhinAer AE reports met these criteria. Epistaxis was the most commonly reported AE for both Clarifix (n=28, 90.3%) and RhinAer (n=28, 90.3%) devices. Out of all of the reported AEs, RhinAer patients underwent significantly more related hospitalizations than Clarifix patients (n=23, 74.2% vs n=11, 35.5%, p<.05). RhinAer patients also underwent significantly more transfusions than Clarifix patients (n=16, 51.6% vs n=4, 12.9%, p< .05). The majority of AEs resulted in Grade 3-4 complications, requiring major intervention or posing life-threatening harm to patients (n=27, 87.1% Clarifix vs n=25, 80.6% RhinAer).

Conclusions: Both cryoablation and radioablation have the potential to result in AEs that cause significant harm to patients, particularly severe epistaxis. Despite a favorable safety profile and minimally invasive nature, patient counseling on potential risks is essential.