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Background: Gastroesophageal reflux disease (GERD) is the most common esophageal disorder and Laparoscopic Nissen fundoplication is currently the gold standard for the surgical treatment of GERD. Recently, transoral insicionless fundoplication (TIF) procedure has been introduced. The device is passed into the stomach, where it deploys full-thickness fasteners to create a gastroesophageal flap valve mechanism. The efficacy of the second generation TIF 2.0 procedure in a highly selected population was evaluated retrospectively.Methods: Patients were selected based on the presence of proton pump inhibitor (PPI) responsive typical GERD symptoms (heartburn and/or regurgitation), absence of hiatal hernia and positive esophageal pH testing with symptom correlation. Patients with Barrett’s esophagus or severe esophagitis were not included. This group of patients represents our entire clinical experience with the TIF 2.0 procedure.Results: Eleven patients (6 men and 5 women) underwent the TIF 2.0 procedure between April 2008 and July 2009. Mean age and body mass index were 50.9 (range, 27-81) years and 23.3 (range, 19.6-29.3), respectively. ASA classification included 1 (n=1), 2 (n=8), and 3 (n=2). The procedure time was 116 minutes (range, 73-193 min) and the length of hospital stay was 1 day (1-3 days). All patients had post-operative upper abdominal or shoulder pain which required narcotic analgesia for a mean of 1 day (range, 1-5). The major complication rate was 27.3% (3/11), which included esophageal perforation (n=1), hemorrhage requiring transfusion (n=1) and permanent numbness of tip of tongue (n=1). All complications were treated non-operatively. At mean of 10.7 months follow-up (range, 4-19 months), the recurrent symptoms were heartburn (3/11), regurgitation (3/11), dysphagia (1/11), and atypical symptoms (3/11). Thirty-seven percent of patients have completely discontinued PPI therapy and 37.5% have been able to decrease their dose or change to H2 blockade. Three patients (27.3%) have required redo-TIF procedure and 4 patients (36.4%) have been converted to laparoscopic Nissen fundoplication for recurrent symptoms and endoscopically confirmed valve failure. Fifty-five percent (5/9) of patients were satisfied with the outcome of the TIF 2.0 procedure and 44% (4/9) would recommend it to a friend.Conclusion: At short-term follow-up, the TIF 2.0 procedure is associated with high complication and symptomatic failure rates requiring re-intervention. TIF 2.0 should not be performed outside of a clinical trial.