This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
5.1 One case series reported 3 deaths and 22 complications overall (not otherwise defined) in patients treated by radiofrequency ablation for gastro-oesophageal reflux disease (number of procedures to which these events relate not known).
5.2 Mucosal bleeding was reported in 3% (3/90) of patients in a case series of 90 patients. Superficial mucosal injury was reported in 2% (2/90) of patients in the same study. All these complications resolved within 1 week of the procedure.
5.3 Prolonged gastroparesis was reported in 1 patient in a case series of 56 patients: this resolved within 8 weeks.
5.4 The specialist advisers stated that oesophageal perforation is an adverse event which, although rare, is generally acknowledged. The specialist advisers advised of a theoretical risk of developing oesophageal cancer which they considered might be a consequence of long-term unrecognised reflux.